Indications
Cavir is prescribed for managing chronic hepatitis B virus infection in adults and pediatric patients aged 2 years and above, showing signs of active viral replication and either sustained elevation in serum aminotransferases (ALT or AST) or histologically active disease.
Pharmacology
Entecavir, the active ingredient, functions by competitively inhibiting all three activities of the HBV polymerase (reverse transcriptase, rt): base priming, reverse transcription of the negative strand from the pregenomic messenger RNA, and synthesis of the positive strand of HBV DNA. Upon activation by kinases, the drug incorporates into the DNA, ultimately inhibiting the HBV polymerase activity.
Dosage & Administration
The recommended dose of Entecavir for chronic hepatitis B virus infection in nucleoside-treatment-naive adults and adolescents aged 16 years is 0.5 mg once daily. For individuals with Lamivudine-refractory or known Lamivudine or Telbivudine resistance mutations, the recommended dose is 1 mg once daily. For patients with decompensated liver disease (adults), the recommended dose is 1 mg once daily. Entecavir should be taken on an empty stomach (at least 2 hours after a meal or 2 hours before the next meal).
Missed Dose
If it’s nearly time for the next dose, skip the missed dose and take the next one at the scheduled time. Avoid doubling the dose to compensate for the missed one.
Interaction
Co-administration of Cavir with Lamivudine or Adefovir dipivoxil doesn’t result in significant drug interactions. However, the effects of co-administration with other drugs eliminated through renal or affecting renal function haven’t been fully evaluated. Close monitoring for adverse events is advisable when coadministered with such drugs.
Contraindications
Entecavir is contraindicated in individuals with previously demonstrated hypersensitivity to Entecavir or any component of the product.
Side Effects
Common adverse events may include headache, fatigue, dizziness, and nausea.
Pregnancy & Lactation
Data on the effect of Entecavir on HBV transmission from mother to infant is lacking. Therefore, caution is advised. It’s unknown whether Entecavir is excreted in human milk, hence mothers should refrain from breastfeeding if taking Entecavir.
Precautions & Warnings
Lactic acidosis, including fatal cases, has been reported with the use of nucleoside analogues alone or with antiretrovirals. Severe acute exacerbations of hepatitis B have been observed in patients discontinuing anti-hepatitis B therapy, including Cavir.
Use in Special Populations
Safety and effectiveness of Cavir in pediatric patients below 2 years haven’t been established. In geriatric patients, dose selection should be cautious, and renal function monitoring may be advisable.
Overdose Effects
No Cavir overdosage experience has been reported in patients. Healthy subjects receiving up to 20 mg daily for up to 14 days and single doses up to 40 mg had no unexpected adverse events. If overdosage occurs, monitor for toxicity and provide standard supportive treatment as necessary.
Therapeutic Class
Cavir belongs to the therapeutic class of medications for hepatic viral infections, specifically Hepatitis B.
Storage Conditions
Store Cavir in a dry place below 30°C. Protect from light and keep out of the reach of children.
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